At a Glance
- Tasks: Manage Distribution Anchors and ensure compliance with global safety regulations.
- Company: Join Johnson & Johnson, a leader in healthcare innovation.
- Benefits: Competitive salary, health benefits, and opportunities for professional growth.
- Other info: Dynamic team environment with a focus on continuous improvement.
- Why this job: Make a real impact in global safety while developing your skills.
- Qualifications: Degree or relevant experience in pharmacovigilance and regulatory reporting.
The predicted salary is between 40000 - 50000 £ per year.
Johnson & Johnson seeks a Distribution Configuration Management (DCM) Analyst to manage Distribution Anchors (DAs) in the Global Safety System across multiple international sites.
Essential Job Duties and Responsibilities
- Execute daily operational activities for the setup and maintenance of DAs.
- Collaborate with internal and external partners to support DA maintenance for regulatory reporting.
- Write and update procedural documents and contribute to continuous process improvement.
- Train and mentor other DCM staff.
- Lead interactions with Local Safety Officers to gather regulatory intelligence.
- Document local country regulatory requirements and translate them into technical requirement specifications.
- Create Distribution Anchors directly in the Global Safety System.
- Manage daily workload and ensure timely completion of distribution rule tasks.
- Conduct quality control and informal testing of new or modified DAs.
- Maintain liaison with the DCM team regarding workload management.
- Deputise for Manager/Director as needed.
- Participate in team meetings and resolve processing issues.
- Drive continuous improvement of processes to meet internal and regulatory standards.
- Develop metrics to monitor key performance indicators across DCM areas.
- Assist Manager with process implementation and issue management.
Operational Activities
- Identify and resolve issues; prepare documentation and options for solutions when escalation is required.
- Perform impact assessments and manage bolus activities related to DAs.
- Provide clarification of procedures and ensure compliance when collaborating with business partners and regulatory authorities.
- Support Service Level Agreements between GMSO and Marketing Authorization Holders or Pharmacovigilance Agreements.
- Oversee DAs within the Global Safety system.
- Liaise with functional areas to resolve queries and issues.
Projects and Initiatives
- Act as Subject Matter Expert for regulatory reporting intelligence, quality monitoring, process/system improvement, compliance and quality metrics, controlled document creation, quality investigations, and CAPA activities.
- Identify and develop solutions for improvement areas, including technology automation.
Quality and Compliance
- Develop and update standard operating procedures and controlled documents for task coordination, business continuity, and audit readiness.
- Represent DCM in audits and inspections when requested.
- Investigate, document, and track compliance data and identify trends.
- Maintain knowledge of regulatory guidance for ICSR processing.
Minimum Qualification Education
- Degree and/or relevant work experience; advanced degree preferred.
Required Experience
- Understanding of U.S. and EU electronic regulatory reporting requirements for ICSR.
- Experience in pharmacovigilance operations including single-case processing, database queries, and expedited reporting.
- Knowledge of regional and global safety regulations.
- Understanding of technologies, systems, and databases related to E2B electronic reporting.
- High reliability, compliance with legal and company guidelines.
- Strong organizational and communication skills, including presentation abilities.
- Ability to produce high-quality work under time-critical and high-pressure situations.
- Project Management skills desirable.
Preferred Skills
- Experience with automation of process steps.
- Knowledge of EMA, FDA, and other regulatory authorities.
Distribution Configuration Management Analyst in High Wycombe employer: 7360-Janssen-Cilag Limited Legal Entity
At Johnson & Johnson, we pride ourselves on being an exceptional employer, offering a dynamic work environment that fosters collaboration and innovation. As a Distribution Configuration Management Analyst, you will benefit from our commitment to employee growth through training and mentorship opportunities, while also enjoying a culture that values compliance and continuous improvement. Located in a global hub for healthcare, our team is dedicated to making a meaningful impact on patient safety and regulatory excellence.
Contact Details:
7360-Janssen-Cilag Limited Legal Entity Recruitment Team
StudySmarter Expert Advice🤫
We think this is how you could land Distribution Configuration Management Analyst in High Wycombe
✨Tip Number 1
Network like a pro! Reach out to current or former employees at Johnson & Johnson on LinkedIn. A friendly chat can give you insider info and might even lead to a referral, which is always a bonus.
✨Tip Number 2
Prepare for the interview by knowing your stuff! Brush up on the latest in regulatory reporting and pharmacovigilance. Show them you’re not just a candidate, but someone who’s genuinely interested in the role and the company.
✨Tip Number 3
Practice makes perfect! Get a friend to do a mock interview with you. Focus on articulating your experience with DAs and compliance processes clearly. The more comfortable you are, the better you'll perform!
✨Tip Number 4
Don’t forget to follow up! After your interview, send a thank-you email to express your appreciation for the opportunity. It’s a small gesture that can leave a lasting impression and keep you top of mind.
We think you need these skills to ace Distribution Configuration Management Analyst in High Wycombe
Some tips for your application 🫡
Tailor Your Application:Make sure to customise your CV and cover letter for the Distribution Configuration Management Analyst role. Highlight your relevant experience in regulatory reporting and pharmacovigilance, as this will show us that you understand what we're looking for.
Showcase Your Skills:Don’t just list your skills; demonstrate them! Use specific examples from your past work that relate to the job description. We want to see how your organisational and communication skills have made a difference in your previous roles.
Be Clear and Concise:When writing your application, keep it straightforward. We appreciate clarity, so avoid jargon and get straight to the point. Make sure your key achievements stand out, as we’re keen to see what you can bring to our team.
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, you’ll find all the details you need about the position there!
How to prepare for a job interview at 7360-Janssen-Cilag Limited Legal Entity
✨Know Your Regulatory Stuff
Make sure you brush up on U.S. and EU electronic regulatory reporting requirements for ICSR. Being able to discuss these in detail will show that you understand the core of what the role entails.
✨Showcase Your Collaboration Skills
Since the job involves working with internal and external partners, prepare examples of how you've successfully collaborated in the past. Highlight any experiences where you’ve trained or mentored others, as this is a key part of the role.
✨Be Ready to Discuss Process Improvement
Think about times when you've identified areas for improvement in your previous roles. Be prepared to share specific examples of how you implemented changes and the positive outcomes that resulted.
✨Demonstrate Your Organisational Skills
This position requires managing a daily workload and ensuring timely completion of tasks. Prepare to discuss your time management strategies and how you prioritise tasks under pressure.
